MAUDE Adverse Event Report: PRODICY DIABETES CARE LLC PRODIGY AUTOCODE; GLUCOSE OXIDASE, GLUCOSE

Device Problem Moisture Damage (1405)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the patient got their device wet.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PRODIGY AUTOCODE
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): PRODICY DIABETES CARE LLC
• MDR Report Key: 17532286
• MDR Text Key: 321254461
• Report Number: MW5139194
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1